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Complementary and Alternative Therapies: Herbal Medicines. Uncritical enthusiasm. Uninformed repulsion . C urrent methodologies not a dequate. Where is the evidence?. Dr. Ranjit Roy Chaudhury Dr. Urmila Thatte India. Challenges in clinical evaluation of alternative medicine s.

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slide1

Complementary and Alternative Therapies: Herbal Medicines

Uncritical enthusiasm

Uninformed repulsion

Current methodologies not adequate

Where is the evidence?

slide2

Dr. Ranjit Roy Chaudhury

Dr. Urmila Thatte

India

Challenges in clinical evaluation of alternative medicines

1 literature search
1. Literature search
  • Paucity of published data
  • Local Clinical Practice not documented
  • Good literature search difficult
  • Journals not indexed, not peer reviewed, poor quality data
  • Information in local language; needs correct “interpretation”
2 starting material
2. Starting material
  • Identification and source of herb

Bacopa monnieri

Centella asciatica

Brahmi

2 starting material5
2. Starting material
  • Single herb? Multiple herbs?
  • Purity: WHO criteria
  • Continuous Supply, Quality Control and Stability of batches: multi-centric studies
  • Standardisation of extract: bioassay guided
slide6

Chemical markers vs. activity

  • Estrogenic activity found in a vegetable oil
  • Plant obtained in July: Active; that obtained in April: Inactive
  • HPTLC fingerprinting
slide7

Chemical markers

July: Active vs. April: Inactive

Mobile phase - II

Mobile phase - I

Mobile phase - III

3 pre clinical work up
3. Pre-clinical work-up
  • How much toxicity testing is needed?
    • Local Regulatory status (India: Categories)
  • Lack of pre-clinical data: difficulty to extrapolate animal studies
4 clinical studies
4. Clinical Studies
  • Which formulation: traditional/new
  • What dose (crude/extract), regimen, duration: no pre-clinical data, rely on traditional literature
4 clinical studies planning protocol
4. Clinical Studies: planning protocol
  • Sample size
  • Choosing efficacy and safety variables and end points
  • Inclusion/Exclusion criteria
  • Individualisation: constitution
response to medications depends on prakriti constitution
Response to medications depends on prakriti (constitution)

Anti-epileptic medication

responders

Non- responders

4 clinical studies design
4. Clinical Studies: Design
  • open label
  • observational
  • n=1 studies
  • “Add-on design”: ethics
  • Blinded studies difficult: Assessor blind possible (ksharasootra)
4 clinical studies use of placebo
4. Clinical Studies: use of placebo
  • Ethics
  • Difficult to match colour, taste, odour, flavour or formulation of herbal product
  • Should be truly inert
ethanol induced gastric mucosal damage in rats evans blue leakage in gastric tissue content ug g
Ethanol induced gastric mucosal damage in rats : Evans blue leakage in gastric tissue & content (ug/g)

IMP011

*

NS

*

placebo

*p< 0.05 vs. D/W; NS = not significant

vs. IMP-011.

4 clinical studies rcts
4. Clinical Studies: RCTs
  • Reduces bias  
  • Difficult to design RCTs for alternative medicines:
    • Involve complex interventions
    • Cultural and social influences
    • Are holistic in nature
    • Focus on symptoms
    • Intra & inter variation in responses
    • Require long duration of therapy
5 pharmacokinetics
5. Pharmacokinetics
  • Plasma estimation of “active” molecules difficult
  • May be more than one “active molecule”
  • Metabolic changes during absorption possible
  • “Effect kinetics”: attractive option
6 ethics
6. Ethics
  • Coinvestigator fromalternative system
  • Standards of care of control group: HIV research
  • Informed consent: Meaningful, vernacular, easier?
  • Attitude towards alternative therapy: safe – patient information sheet may mislead
6 ethics18
6. Ethics
  • Cultural overtones
  • Translating research findings into components of accessible care
  • Commercialisation of folklore medicine: rights/share of tribe or community to be given
7 regulatory scenario
7. Regulatory Scenario
  • US FDA & Europe: food supplements; FDA guidelines available
  • India:
    • DCGI, State FDAs
    • Special emphasis on herbal research: Categories
8 analysis
8. Analysis
  • What degree of improvement to expect?
  • What should be criteria for defining success?
  • Comparison with modern potent medicines?
8 analysis21
8. Analysis

Rate of decrease in wound score

**

Student’s unpaired

t-test: ** p<0.01vs.GA

**

Recurrence of diarrhea in malnourished children

*** Chi square test p<0.001 vs. Control

5 rules for clinical research in alternative medicines
5 rules for Clinical Research in Alternative Medicines
  • Literature review: look at traditional literature, collate experiential data, proper interpretation
  • Consult qualified expertise
  • GMP for investigational products
  • Plan a good protocol: keep in mind the traditional medicine philosophy
  • Adhere to ethical and regulatory aspects